Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-85
SponsorRennes University Hospital
About this trial
The aim of this pilot study is to evaluate muscular activity during a single session of surface electromyography controlled exergame (muscle activation, number of contraction…) in cerebral palsy kids, hemiparetic adults and healthy controls.
Secondary aims are to assess different game mode (one-player, coactive two-player or competitive two-player and different gameplay (a rhythm and a platform gameplay) on muscle activation, number of contraction and on participant's experiences. Another aim is to assess enjoyment, motivation, flow and usability in hemiparetics adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants with cerebral palsy who are able to walk, GMFCS stages I through III, hemiplegic, diplegic, or quadriplegic
Aged 7 to 17 years
With palpable contractions of the target muscles (triceps surae and tibialis anterior) (≥ 1 on the Medical Research Council [MRC] scale)
Having received verbal and written information about the protocol, having agreed to participate in this study, and having signed a consent form if the participant is 15 years of age or older
Disqualifiers
Surgery on the lower extremities within the past 6 months
A botulinum toxin injection into the triceps surae and/or the tibialis anterior within the past 3 months
Pain during dorsiflexion or plantarflexion of the ankle joint
Cognitive impairments limiting participation
Trial design
Design model
Single group
Treatments tested in this trial
Surface electromyography (sEMG)-controlled rehabilitation game
Other interventionDuring the game session, participants will be paired in advance of the visit (an adult participant with hemiparesis paired with another adult participant with hemiparesis, or a healthy volunteer and a child with cerebral palsy paired with another child with a cerebral palsy) to allow for testing of different conditions for the electromyography-controlled rehabilitation game. The estimated duration for each participant is 1 hour and 30 minutes, including a 30-minute game session. Participants will play the rehabilitation game under different modalities : individually, in pairs in a co-active mode, or in a competitive mode. In individual mode, they play two different games a rythm game (following the musical tempo by alternating agonist/antagonist contractions) and a target game (the participant controls a rocket that must hit targets based on the intensity of muscle contractions and the muscle being activated....). The game modalities will be presented in a randomized order.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Surface EMG-controlled Rehabilitation GameExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Muscle activation level
calculated as the mean of the maximum values of the normalized RMS envelope of the EMG signal during each muscle contraction of the Tibialis Anterior and Lateral Gastrocnemius muscles
Time frame
Day 1 : during the rhythm game in the individual modeSecondary outcomes
1
Muscle activation
calculated as the mean of the maximum values of the normalized RMS envelope of the EMG signal during each muscle contraction of the Tibialis Anterior and Lateral Gastrocnemius muscles
Time frame
Day 1 : between game mode2
Amount of activity performed
Number of contractions performed
Time frame
Day 1 : between game mode3
Amount of activity performed
Total duration of muscle contractions
Time frame
Day 1 : between game mode4
Amount of activity performed
Duration and number of muscle contractions performed at predefined target muscle activation intensities
Time frame
Day 1 : between game modeSponsors and contacts
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Source ClinicalTrials.gov
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